510(k) · Cleared
ClearedJoinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joinsoon Electronics Mfg Co, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 21, 2010 as substantially equivalent to K042202 (Oriental System Technology, Inc., 2004) after a 79-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jul 21, 2010
- Review
- 79 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K852954 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK852954 B-D Digital Fever ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1985
- 3 generations backK962497 Q-Tips, Faichney, Private LabelFaichney Medical Co. · 1996
- 2 generations backK992601 Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103…Oriental System Technology, Inc. · 1999
- 1 generation backK042202 Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312…Oriental System Technology, Inc. · 2004
- This deviceK101232 Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer…Joinsoon Electronics Mfg Co, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852954 | B-D Digital Fever Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985 | — |
| −3 | K962497 | Q-Tips, Faichney, Private Label | Faichney Medical Co. | 1996 | — |
| −2 | K992601 | Temp Teller - Digital Thermometer, Models DT-101, DT-102, DT-103, DT-201… | Oriental System Technology, Inc. | 1999 | — |
| −1 | K042202 | Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412… | Oriental System Technology, Inc. | 2004 | — |
| 0 (this device) | K101232 | Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001 | Joinsoon Electronics Mfg Co, Ltd. | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042202 | Tempteller - High Speed Digital Thermometers, Models DT-302, DT-312, DT-412, DT-502Summary page 1…FLL 6. Predicate Devices: TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412, DT-502 Previously cleared 51 0(k) number: K042202 7. Device Description The device Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101232: Joinsoon Electronics MFG CO. LTD High Speed Digital Thermometer, Model TC-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101232
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026